Cognitive remediation program for depression

A Phase III, Randomized, Active Comparator-controlled, Clinical Trial to Study the Efficacy and Safety of the INtegral Cognitive REMediation Program (INCREM) in Patients with Depression

This study tests a new program to help people with depression improve their thinking skills and daily functioning, even if their mood gets better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 296 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (other)
• Locations: 1 site (Barcelona, Catalonia)
• Trial ID: NCT06590025 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of the INtegral Cognitive REMediation Program (INCREM) designed for individuals suffering from Major Depressive Disorder (MDD). It focuses on addressing cognitive symptoms that significantly impact daily functioning, even when mood symptoms improve. Participants will undergo cognitive remediation and psychoeducation to enhance their cognitive abilities and overall recovery. The study aims to assess improvements in cognitive function and functional recovery in patients with depression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with either remitted or active episodes of major depression and cognitive symptoms.

Not a fit: Patients with severe treatment-resistant depression or those with significant comorbid psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve cognitive functioning and quality of life for patients with depression.

How similar studies have performed: Other studies have shown promise in cognitive remediation for depression, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17)
* showing cognitive symptoms (scores below 80 on the SCIP)
* with functional difficulties (scores above 12 on the FAST).

Exclusion Criteria:

* IQ below 85;
* any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
* being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and antioxidant supplements;
* use of systemic antibiotics the last 2 months;
* presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
* for bipolar disorders, presence of a manic or mixed episodes in the last three months;
* accomplish criteria for severe treatment resistant depression;
* patients who had received electroconvulsive therapy in the previous year;
* patients receiving any other structured psychological intervention in the 3 months prior to the study;
* not having the necessary electronic means (computer or tablet) or internet connection to be able to participate.

Where this trial is running

Barcelona, Catalonia

• Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau — Barcelona, Catalonia, Spain (RECRUITING)

Study contacts

• Principal investigator: Maria J Portella, Dr — Institut de Recerca Sant Pau
• Study coordinator: Alejandra Espinosa, Dr.

Conditions: Depression, Depressive Disorder, cognitive symptoms, cognitive remediation, rehabilitation, major depressive disorder, functional recovery